Nuts and Bolts of Band Revisional Surgery, Part 2

Photo by M Clock

So, in keeping with the theme of the unexpected-

We went on a charter fishing trip out of Rock Harbor in Cape Cod recently.  We had a great time, caught some nice Bluefish and Sea Bass.  I came across a sticker that some may find unusual.

Why is the Captain against seals on Cape Cod?  You would think that he would be pro-sea life in general, not just certain kinds of sea inhabitants.

There is a good reason he's anti-seal of late, and you may be aware of at least part of the problem, as it involves increasing numbers of Great White sharks off of Chatham, and some of the outer Cape beaches.

Since the seals are included in a congressional act passed a number of years ago that protects them and other endangered sea life, it seems that the program has been in some ways essentially too successful.  Seals are becoming quite a nuisance, given their bloated numbers on Monmoy, and are not only an attractant to Great White Sharks, but also eating up the fish in the Bay, as well as terrorizing the commercial fisherman in the Cape Cod Bay's catch, and hence their livelihood.  More info can be found at this link to a recent NBC news report from this month.

Anyway, back to the issue at hand - Band revisional surgery.  You might want to grab a cup of coffee or tea...this one will take a little to get through.

Part 2

So, we have come to the conclusion that a patient needs a Band revisional procedure.  The next step is putting all the needed components together to assure the best chance at post operative success.  Just as important, and somewhat out of order in this discussion, is the question as to whether insurance will even cover the procedure in the first place.

There are a number of questions to ask to be able to assure insurance reimbursement, which is imperative to both the patient and ourselves, the surgical group that will do the procedure.  There are a few relatively hard and fast rules, and then a number of other variables to keep in mind. There is also the reality that things do change as far as insurance company coverage goes, and we frequently find these out in retrospect as "new" ground rules.

The easy part are the main concepts that are fairly constant.  'Covered' revisional procedures usually stem from a mechanical failure of one of the components of the Band (Band itself, or access port), or the occasional acute or chronic issues that are not able to be remedied through fluid adjustments or conservative means.  Chronic and severe reflux, recurrent gastric prolapse, and Gastric erosion falls into this category.

For the 'failure to lose weight' category, it gets a little more sticky.  Firstly, we need to screen these folks to assure that they have given the post operative care a reasonable try with regular visits, dietary adherence, exercise schedules, and adequate time from surgery (usually around 2 years).  The behavioral component by the patient will be required no matter what procedure we are converting their Band to, and weight loss and maintenance of that loss is very directly related to compliance on those behavioral variables to be successful.

Secondly, the insurance again comes in to play.  Most, but certainly not all, insurance plans follow the initial guidelines of BMI and comorbidites to 're-qualify' a patient, (BMI 35-39 with comorbidities, BMI of 40 or greater)but some consider those same standards a bit more strictly, perhaps looking for a reason not to reimburse the revisional procedure.

For example, we had a patient who didn't qualify for surgery with a BMI of 38 even with OSA recently, as the Pulmonary consult note characterized the OSA as "mild, yet still requiring an appliance" (C Pap).  We have also had experiences with patients having HTN and DM2 who were denied in the recent past due to the 'controlled' nature of their diseases, due to the fact they were only on 1 medicine (HTN) and not on insulin yet (DM 2).  The majority of our previous experience was that OSA, DM 2, and usually HTN, were relatively absolute qualifiers for insurance coverage for surgery, but not so anymore, especially when a revision is on the table.

One commonly-held local / regional HMO is adamant that no revisional procedure will be approved without a peer to peer review, and most of these remain unapproved even with that level of interaction and 'expected' qualification for surgery.

I do understand the position of the insurance company to a degree.  First, the dramatic increase in Bariatric surgeries over the past 8-10 years, and now another potential wave of 're-do's" that may need to be done.  Difficult to budget for from their perspective, and difficult to get excited about, as there truly is a paucity of evidenced-based data out there, thus far, on the likelihood of success after undergoing such a procedure.

Additionally, with some of the patients, it could be argued that there is a significant behavioral component to their failure, and it is furthermore difficult to predict who will likely do well after a revisional Band procedure.

Sorry for the lengthy insurance diversion, but it is necessary to review potential barriers to access to surgery, for better and for worse.

And lastly, from a semantics standpoint, we do require the patient to go through a majority of the same initial process that they participated in the first time, getting to their first surgical procedure.  They will need to see Psych again, their PCP for clearance, likely lose some weight (5-10%) before surgery,  get a full battery of labs tests and possibly an EGD, as well as seeing the Dietitian again to discuss both their lack of weigh loss after their last procedure in addition to the education involved in their new procedure of choice.

It is stressed throughout this pathway, essentially from the start as we entertain the possibility of a revision, that revisional surgeries are not a walk in the park.  They generally take a number of hours more to do, nationally have a 30% higher likelihood of complications, and are not guaranteed on their own to finally get the patient to lose weight long term and keep it off.

Having the patient understand that a revision is not "the easy way out", a guarantee of long term success, or a whimsical choice because "the Band isn't working for me" is key to getting off to a good start as we pursue this kind of surgery.

All the above being said, we do Band revisional surgeries with some frequency.  We have had a number of successful conversions from Band to Bypass or Sleeve.  And,  especially in the cases where patients have complications from their Bands, they are very happy to have their revisional procedures done, ameliorate their complaints, and get back to the business of losing weight and keeping it off..

The Nuts and Bolts of Band Revisional Surgery

Photo by M Clock

You don't always get what you expect.

Take the example of the water temperature on Cape Cod.  If your expectation is that the water should be warm based on your previous ocean experiences, you will be in for a surprise.  The Caribbean it is not, but unto itself it is a beautiful place in so many ways.

The more I thought about writing this post, the more the idea resonated as an increasingly important concept to share.  The more I thought about it, and saw patients this week in the office that this directly applied to, the more I envisioned this post growing substantially in length.

As I have referred to before, one of the 'secrets' of a rip-snorting Blog is that the posts are succinct and bite-sized in their approach.  So....

Let's do this in three parts.  Part one will identify the scope of the problem.  Next will be the process the patient goes through to get the revisional procedure, including the insurance aspects, and I will finish up with Part 3, detailing how we tailor the surgery choice based on the individual patient's needs and presentation.

Part 1

Band revisions are being done a little more commonly these days in our practice.  This stems from a small segment of our Band population having mechanical issues, such as Gastric Prolapse, pouch dilation, esophageal issues non-remedied by extracting fluid from the Band, as well as the rare case of gastric erosion.

Probably the most common reason, though, is lack of weight loss.  This usually has a significant behavioral side (not eating the correct foods the correct way, or lack of consistent exercise, or poor office follow up) but that can be occasionally be exacerbated by other mechanical issues of improper restriction which can 'encourage' maladaptive eating patterns that lead to weight loss plateaus, weight gain, or weight regain.

We commonly deal with these issues on an acute level in follow up, as long as the patient presents for us to offer our assistance and our clinical expertise. However when left unchecked for months or years on a subacute or smoldering level, they can become difficult to overcome.

Even so, both we and the patient's insurance company generally want to see a proven record of a reasonable attempt of usually 2 years of consistent effort at following through on the necessities of aftercare that are stressed repetitively in a multidisciplinary way.

Next up will be a more detailed description on what the patient needs to go through to get their revisional weight loss surgery, including some of the insurance hoops that have become necessary, as well as the risk/benefit ratio of going to the OR again to improve upon a patient's suboptimal outcome with their Gastric Banding.

One last comment.  As I have stated a few times earlier in this Blog, the majority of our Band patients are still doing well with their weight loss and are enjoying their "tool" as they gain control over their eating habits and resultantly their weight.  Some of those patients, for the first time in their lives.  But if that is what is needed / desired, it can usually be accomplished by switching out to a different procedure such as a Bypass or a Sleeve as either a one-time procedure, or occasionally in a 2 stage process.

One Bad Apple Could Spoil the Whole Bunch (Girl!)

Photo by M Clock

(Yes, those are cherry tomatoes, not apples...but I think the same principle applies)

So, why is this post labeled the way it is?

I think it the saying truly can mean what it implies - that one small part of a whole group is capable of ruining the homogenous group via it's unique way of deviating from the norm. Just by the mere fact that it is, for it's greater part, a genuine part of the whole group doesn't free it from possibly doing damage to the whole. In fact, that characteristic can uniquely enable it to do so if not cared for in the proper way.

So where are we going with this?

Glad you asked.

"Way back" in 2006, the decision was made by CMS (Centers for Medicare and Medicaid Services) to require centers that provide Bariatric Surgery services to become certified to do so, as a Center of Excellence (COE), in order to approve of the location that provides the surgical service as well as clear payment to those centers for reimbursement.

The idea at the time was to encourage high volume centers to go through the process to become certified, and therefore be able to establish a a new standard benchmark, ensuring quality prospectively from that point on. Historically, Bariatric Surgery was becoming safer at that time, and the reason resided in the fact that the learning curve in going from open surgeries to laparoscopic procedures was being realized nationally.

Significant gains in safety and outcome have in fact been realized across the rapidly expanding Bariatric Surgery sub specialty, but the consideration of a new ruling on the matter by CMS has that situation potentially in a bit of jeopardy.

CMS is considering a new ruling this Fall that could lift the facility certification / COE designation as a requirement for coverage of approved services, which may open the door for access to non-accredited centers for these patients, it could substantially increase morbidity and mortality of these patients.

CMS is basing their consideration this issue as a result of a study that came out earlier this year showing "no significant difference" between designated COE's and non-accredited centers in terms of complications and outcome.

Just this week, the ASMBS, ACS, The Obesity Society, The American Society of Bariatric Physicians, and The Society of American Gastrointestinal Endoscopic Surgeons collectively wrote that they "strongly oppose" the CMS's decision to overturn the current established policy.

A counter argument to that study (and the current position of CMS on changing their policy), apart from reasonable intuition that higher volume centers have better outcomes, will be argued by a study currently in press,  in the journal of Surgical Endoscopy.  That study showed an alarming increased in-hospital mortality rate of 3X higher in non-accredited centers vs. those that were COE's (0.22% vs. 0.06%).

While access to care may be the effect that CMS is after by "freeing up" the ability of more centers to be able to do weight loss procedures, should more frequent events of morbidity and mortality occur than is currently the case, access may in fact be diminished as referring physicians once agin think twice, or more, about referring their patient for surgery in the first place.

In this specialty, what happens "globally" can certainly effect local perception of safety, which would be a shame after we, as a specialty, have come so far.  I will stay on top of any developments in this issue, and make you aware what, or IF, any changes occur.